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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66626

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 16, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Microgenics Corp

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Microgenics Corporation, located at Fremont, CA., part of Thermo Fisher Scientific The CEDIA Tobramycin II Assay is an in vitro diagnostic medical device intended for the quantitation of Tobramycin in human serum or plasma.

Z-0513-2014
Recall number
Z-0513-2014
Initiated
October 16, 2013
Classification
Class II
Status
Terminated
Recalling firm
Microgenics Corp
Quantity
370 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot Number: 60169764) due to calibration stability problem relating to two complaints received.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot Number: 60169764) due to calibration stability problem relating to two complaints received.

Code information

Lot Number: 60169764

Distribution pattern

Worldwide Distribution - USA including WI, UT, ND, MT, WA, CA, OK and Internationally to Australia, Canada, and Germany.